A Successful Instrument Manufacturer Must Anticipate The Availability Of Funds And Drivers For Additional Data.

The Societal Values Must Be Served.

Instrument Companies Which Do Not Adequately Address The Needs Of The Testing Community Do Not Survive.

7USER REQUIREMENT SPECIFICATION (URS)

Sales And Marketing Personnel Visit With Users To Identify Needs And Bells And Whistles.

Minimum Performance Requirements Must Be Identified.

Focus Groups May Aid In Refining The URSs.

8The Road Forward

The URSs Drive The Development Of Functional Requirement Specifications (FRS) Which Establish The Design Qualification (DQ).

The FRS Are Developed Into The Detailed Design Specification (DDS). The DDS Establishes The Basis For The Installation Qualification (IQ).

The DDS Provide The Basis For Construction.

9(No Transcript) 10FDA CMC Guidance

Methods validation is the process of demonstrating that analytical procedures are suitable for their intended use. The methods validation process for analytical procedures begins with the planned and systematic collection by the applicant of the validation data to support the analytical procedures.

11Instrument ValidationToms Revision

Instrument validation is the process of demonstrating that analytical instruments are suitable for their intended use. The validation process for analytical instruments begins with the planned and systematic collection by the applicant of the validation data to support the analytical applications.

1221 CFR 211.160 (b)(4)

The calibration of instruments, apparatus, gauges, and recording devices at suitable intervals in accordance with an established written program containing specific directions, schedules, limits for accuracy and precision, and provisions for remedial action in the event accuracy and/or precision limits are not met. Instruments, apparatus, gauges, and recording devices not meeting established specifications shall not be used.

13GUIDELINE ON GENERAL PRINCIPLES OF PROCESS VALIDATION, MAY, 1987

1. Equipment and Process

a. Equipment Installation Qualification

b. Process Performance Qualification

Installation qualification - Establishing confidence that process equipment and ancillary systems are capable of consistently operating within established limits and tolerances.

14Coup De Grâce

It is important that the manufacturer prepare a written validation protocol which specifies the procedures (and tests) to be conducted and the data to be collected. The purpose for which data are collected must be clear, the data must reflect facts and be collected carefully and accurately.

In assessing the suitability of a given piece of equipment, it is usually insufficient to rely solely upon the representations of the equipment supplier,

Information obtained from these studies should be used to establish written procedures covering equipment calibration, maintenance, monitoring, and control.

15Continuing 1

Installation qualification studies establish confidence that the process equipment and ancillary systems are capable of consistently operating within established limits and tolerances. After process equipment is designed or selected, it should be evaluated and tested to verify that it is capable of operating satisfactorily within the operating limits required by the process.

16Two Prongs of Equipment Purchasing/Receipt

Good Business Practices ISO Standards

Purchased Goods Must Conform to The Purchasers Requirements and Specifications

cGMP

Equipment Must Be Fit For Intended Use

Equipment Must Conform to Requesters Specifications

Performance Assessment

17ISO 9001-2000

7.4 Purchasing

7.4.1 Purchasing process

The organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product. The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization's requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 4.2.4).

18

7.4.2 Purchasing information

Purchasing information shall describe the product to be purchased, including where appropriate

a) requirements for approval of product, procedures, processes and equipment,

b) requirements for qualification of personnel, and

c) quality management system requirements.

The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.

19

7.4.3 Verification of purchased product

The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements. Where the organization or its customer intends to perform verification at the supplier's premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.

20ISO 17025 Section 4.6.2

(a) All incoming supplies and reagents that can affect the quality of test results shall be shown to be suitable for their intended use through acceptable control sample testing or other system suitability testing prior to their release for routine use or supplier certifications may be accepted after the reliability of the supplies has been established. A program to periodically monitor the supplies must be implemented to assure the continued adherence to those standards.

The small improvement are overshadowed by the fact that most of the adverse quality issues of two decades ago remain. variations in capillary bore and outer dimensions, ovality, random brittleness, and surface activity.

25Fused Silica Capillary 2

Although fused-silica capillary enables separation methods unimaginable prior to its introduction, most manufactured capillaries are highly variable in quality and less than optimal for any application.

26Fused Silica Capillary 3

Not only have fused-silica capillary columns revolutionized GC, but the newer separation science technologies capillary electrophoresis (CE), capillary LC, and capillary electrochromatography (CEC)perhaps would not have been explored without the availability

It is impossible to run all autosamplers at a rsd better than 0.5. In fact, it is difficult to keep them in good enough shape to provide an overall rsd of nmt 1.0. Experience shows a reasonable uncertainty of 2 or more from the autosampler.

33Influence of Poor Peak Shape on Integration This slide courtesy of Waters, Inc.

34BMW Z Decisions 35BMW Z3 36(No Transcript) 37Invicta S1

Engine

4.6 Liter V-8

DOHC Per Bank

320 bhp at 5,900 rpm

300 lb-ft at 4,800 rpm

Performance (claimed)

Top Speed 180 mph

0-60 mph in 5 sec.

0-100 mph in 11 sec.

38Bottom Lines

The World Is Infinitely Complex.

It Is Impossible To Validate The Intricate Minutiae In Complex Systems.

Appropriate Performance Parameters Must Be Established In SOPs To Demonstrate Fitness For Use.

Control Samples Which Challenge The Typical Analytical Method Validation Dimensions Should Be Used.

39What Do We Want From Our Instrument?The Performance Required For Method Validation

Accuracy

Precision

Specificity

Detection limit

Quantitation limit

Linearity

Range

Robustness

Typical Validation Characteristics ICH and, USP lt1225gt

About PowerShow.com

PowerShow.com is a leading presentation/slideshow sharing website. Whether your application is business, how-to, education, medicine, school, church, sales, marketing, online training or just for fun, PowerShow.com is a great resource. And, best of all, most of its cool features are free and easy to use.

You can use PowerShow.com to find and download example online PowerPoint ppt presentations on just about any topic you can imagine so you can learn how to improve your own slides and
presentations for free. Or use it to find and download high-quality how-to PowerPoint ppt presentations with illustrated or animated slides that will teach you how to do something new, also for free. Or use it to upload your own PowerPoint slides so you can share them with your teachers, class, students, bosses, employees, customers, potential investors or the world. Or use it to create really cool photo slideshows - with 2D and 3D transitions, animation, and your choice of music - that you can share with your Facebook friends or Google+ circles. That's all free as well!

For a small fee you can get the industry's best online privacy or publicly promote your presentations and slide shows with top rankings. But aside from that it's free. We'll even convert your presentations and slide shows into the universal Flash format with all their original multimedia glory, including animation, 2D and 3D transition effects, embedded music or other audio, or even video embedded in slides. All for free. Most of the presentations and slideshows on PowerShow.com are free to view, many are even free to download. (You can choose whether to allow people to download your original PowerPoint presentations and photo slideshows for a fee or free or not at all.) Check out PowerShow.com today - for FREE. There is truly something for everyone!

presentations for free. Or use it to find and download high-quality how-to PowerPoint ppt presentations with illustrated or animated slides that will teach you how to do something new, also for free. Or use it to upload your own PowerPoint slides so you can share them with your teachers, class, students, bosses, employees, customers, potential investors or the world. Or use it to create really cool photo slideshows - with 2D and 3D transitions, animation, and your choice of music - that you can share with your Facebook friends or Google+ circles. That's all free as well!

For a small fee you can get the industry's best online privacy or publicly promote your presentations and slide shows with top rankings. But aside from that it's free. We'll even convert your presentations and slide shows into the universal Flash format with all their original multimedia glory, including animation, 2D and 3D transition effects, embedded music or other audio, or even video embedded in slides. All for free. Most of the presentations and slideshows on PowerShow.com are free to view, many are even free to download. (You can choose whether to allow people to download your original PowerPoint presentations and photo slideshows for a fee or free or not at all.) Check out PowerShow.com today - for FREE. There is truly something for everyone!